Dataset Information

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability.

ABSTRACT: The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study were to prepare the SAMS-CI for clinical use, estimate its inter-rater reliability, and collect feedback from physicians on its practical application.For content validity, we conducted structured in-depth interviews with its original authors as well as with a panel of independent physicians. Estimation of inter-rater reliability involved an analysis of 30 written clinical cases which were scored by a sample of physicians. A separate group of physicians provided feedback on the clinical use of the SAMS-CI and its potential utility in practice.Qualitative interviews with providers supported the content validity of the SAMS-CI. Feedback on the clinical use of the SAMS-CI included several perceived benefits (such as brevity, clear wording, and simple scoring process) and some possible concerns (workflow issues and applicability in primary care). The inter-rater reliability of the SAMS-CI was estimated to be 0.77 (confidence interval 0.66-0.85), indicating high concordance between raters. With additional provider feedback, a revised SAMS-CI instrument was created suitable for further testing, both in the clinical setting and in prospective validation studies.With standardized questions, vetted language, easily interpreted scores, and demonstrated reliability, the SAMS aims to estimate the likelihood that a patient's muscle symptoms were attributable to statins. The SAMS-CI may support better detection of statin-associated muscle symptoms in clinical practice, optimize treatment for patients experiencing muscle symptoms, and provide a useful tool for further clinical research.

SUBMITTER: Rosenson RS

PROVIDER: S-EPMC5427100 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability.

Rosenson Robert S RS Miller Kate K Bayliss Martha M Sanchez Robert J RJ Baccara-Dinet Marie T MT Chibedi-De-Roche Daniela D Taylor Beth B Khan Irfan I Manvelian Garen G White Michelle M Jacobson Terry A TA

Cardiovascular drugs and therapy 20170401 2

<h4>Purpose</h4>The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study were to prepare the SAMS-CI for clinical use, estimate its inter-rater reliability, and collect feedback from physicians on its practical application.<h4>Methods</h4>For content validity, we conducted structured in-depth interviews with its original au ...[more]

PMID: 28421332

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Project description:BACKGROUND:Focus on frailty status has become increasingly important when determining care plans within and across health care sectors. A standardized frailty measure applicable for both primary and secondary health care sectors is needed to provide a common reference point. The aim of this study was to translate the Clinical Frailty Scale (CFS) into Danish (CFS-DK) and test inter-rater reliability for key health care professionals in the primary and secondary sectors using the CFS-DK. METHODS:The Clinical Frailty Scale was translated into Danish using the ISPOR principles for translation and cultural adaptation that included forward and back translation, review by the original developer, and cognitive debriefing. For the validation exercise, 40 participants were asked to rate 15 clinical case vignettes using the CFS-DK. The raters were distributed across several health care professions: primary care physicians (n?=?10), community nurses (n?=?10), hospital doctors from internal medicine (n?=?10) and intensive care (n?=?10). Inter-rater reliability was assessed using intraclass correlation coefficients (ICC), and sensitivity analysis was performed using multilevel random effects linear regression. RESULTS:The Clinical Frailty Scale was translated and culturally adapted into Danish and is presented in this paper in its final form. Inter-rater reliability in the four professional groups ranged from ICC 0.81 to 0.90. Sensitivity analysis showed no significant impact of professional group or length of clinical experience. The health care professionals considered the CFS-DK to be relevant for their own area of work and for cross-sectoral collaboration. CONCLUSION:The Clinical Frailty Scale was translated and culturally adapted into Danish. The inter-rater reliability was high in all four groups of health care professionals involved in cross-sectoral collaborations. However, the use of case vignettes may reduce the generalizability of the reliability findings to real-life settings. The CFS has the potential to serve as a common reference tool when treating and rehabilitating older patients.

Project description:ObjectivesAccurate estimation of the risk of SARS-CoV-2 infection based on bedside data alone has importance to emergency department (ED) operations and throughput. The 13-item CORC (COVID [or coronavirus] Rule-out Criteria) rule had good overall diagnostic accuracy in retrospective derivation and validation. The objective of this study was to prospectively test the inter-rater reliability and diagnostic accuracy of the CORC score and rule (score ≤ 0 negative, > 0 positive) and compare the CORC rule performance with physician gestalt.MethodsThis noninterventional study was conducted at an urban academic ED from February 2021 to March 2021. Two practitioners were approached by research coordinators and asked to independently complete a form capturing the CORC criteria for their shared patient and their gestalt binary prediction of the SARS-CoV-2 test result and confidence (0%-100%). The criterion standard for SARS-CoV-2 was from reverse transcriptase polymerase chain reaction performed on a nasopharyngeal swab. The primary analysis was from weighted Cohen's kappa and likelihood ratios (LRs).ResultsFor 928 patients, agreement between observers was good for the total CORC score, κ = 0.613 (95% confidence interval [CI] = 0.579-0.646), and for the CORC rule, κ = 0.644 (95% CI = 0.591-0.697). The agreement for clinician gestalt binary determination of SARs-CoV-2 status was κ = 0.534 (95% CI = 0.437-0.632) with median confidence of 76% (first-third quartile = 66-88.5). For 425 patients who had the criterion standard, a negative CORC rule (both observers scored CORC < 0), the sensitivity was 88%, and specificity was 51%, with a negative LR (LR-) of 0.24 (95% CI = 0.10-0.50). Among patients with a mean CORC score of >4, the prevalence of a positive SARS-CoV-2 test was 58% (95% CI = 28%-85%) and positive LR was 13.1 (95% CI = 4.5-37.2). Clinician gestalt demonstrated a sensitivity of 51% and specificity of 86% with a LR- of 0.57 (95% CI = 0.39-0.74).ConclusionIn this prospective study, the CORC score and rule demonstrated good inter-rater reliability and reproducible diagnostic accuracy for estimating the pretest probability of SARs-CoV-2 infection.

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Dataset Information

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability.

Publications

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability.

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